Suture system and method

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 13/863,917 (now U.S. Pat. No. 9,492,200), filed Apr. 16, 2013. The entire disclosure of which is incorporated herein by reference.

FIELD

This disclosure relates to biological medical devices and methods, and particularly to biological medical suture systems and methods.

BACKGROUND

In many circumstances, it may be desirable to couple two or more bones or tissue segments together. For example, a bunion (hallux valgus) is a common deformity characterized by lateral deviation of the great toe (hallux) on the mesophalangeal joint (where the first metatarsal bone and hallux meet). One method of treating this deformity is to pull the great toe generally into proper alignment using a suture (or the like) disposed around the adjacent, pointer or index toe. In some applications, the two ends of the suture may need to be tied together. Additionally, torn or partially ligaments may be treated by suturing the ligament portions together. Unfortunately, many surgeons are uncomfortable tying knots because of the possibility of the knot becoming loose and/or the difficulty associated with tying a knot during a surgical procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention are set forth by description of embodiments consistent with the present invention, which description should be considered in conjunction with the accompanying drawings wherein:

<figref idref="DRAWINGS">FIG. 1</figref> is a plan view of one embodiment of a suture construct consistent with one embodiment of the present disclosure;

<figref idref="DRAWINGS">FIG. 2</figref> is a close up of region A in <figref idref="DRAWINGS">FIG. 1</figref>;

<figref idref="DRAWINGS">FIG. 3</figref> illustrates one embodiment of forming the passageways through the bones consistent with the present disclosure;

<figref idref="DRAWINGS">FIG. 4</figref> illustrates one embodiment of the suture construct in combination with pull strands consistent with the present disclosure;

<figref idref="DRAWINGS">FIG. 5</figref> illustrates the suture construct disposed within the passageways in the bone consistent with at least one embodiment of the present disclosure;

<figref idref="DRAWINGS">FIGS. 6-12</figref> illustrate various embodiments of suture pins consistent with the present disclosure;

<figref idref="DRAWINGS">FIG. 13</figref> illustrates one embodiment of the suture construct in combination with one embodiment of a pusher consistent with the present disclosure;

<figref idref="DRAWINGS">FIG. 14</figref> illustrates the suture construct in a locked state consistent with at least one embodiment of the present disclosure;

<figref idref="DRAWINGS">FIGS. 15-18</figref> illustrate various steps for forming a suture construct consistent with at least one embodiment of the present disclosure;

<figref idref="DRAWINGS">FIG. 19</figref> illustrates another embodiment of suture system;

<figref idref="DRAWINGS">FIGS. 20 and 21</figref> illustrate installation/reduction steps corresponding to the suture system illustrated in <figref idref="DRAWINGS">FIG. 19</figref>;

<figref idref="DRAWINGS">FIG. 22</figref> illustrates another embodiment of the pusher tubes consistent with the present disclosure;

<figref idref="DRAWINGS">FIG. 23</figref> illustrates a further embodiment of the pusher tubes consistent with the present disclosure;

<figref idref="DRAWINGS">FIGS. 24 and 25</figref> illustrates an embodiment of a suture system in combination with another embodiment of a suture pin for securing two bone fragments;

<figref idref="DRAWINGS">FIG. 26</figref> illustrates an embodiment of a suture system in combination with the suture pin of <figref idref="DRAWINGS">FIGS. 24 and 25</figref> for securing two bones;

<figref idref="DRAWINGS">FIG. 27</figref> illustrates a bottom perspective view of the suture pin of <figref idref="DRAWINGS">FIGS. 24 and 25</figref>;

<figref idref="DRAWINGS">FIG. 28</figref> illustrates a side view of the suture pin of <figref idref="DRAWINGS">FIGS. 24 and 25</figref>;

<figref idref="DRAWINGS">FIG. 29</figref> illustrates a bottom view of the suture pin of <figref idref="DRAWINGS">FIGS. 24 and 25</figref>;

<figref idref="DRAWINGS">FIG. 30</figref> illustrates an end view of the suture pin of <figref idref="DRAWINGS">FIGS. 24 and 25</figref>;

<figref idref="DRAWINGS">FIG. 31</figref> illustrates a cross-sectional view of one embodiment of a suture pin and a contractible loop extending through an opening in a passageway; and

<figref idref="DRAWINGS">FIG. 32</figref> illustrates a cross-sectional view of the suture pin of <figref idref="DRAWINGS">FIGS. 24 and 25</figref> and a contractible loop extending through an opening in a passageway.

DETAILED DESCRIPTION

One embodiment of the present disclosure may feature suture systems and methods for coupling together two bones, bone segments, and/or tissue segments. The suture systems feature an all suture/thread construction which eliminates the need for the surgeon to tie knots during the surgical procedure.

By way of a brief overview explained in greater detail herein, one aspect of the present disclosure features a suture system which may be used for the treatment of hallux valgus (i.e., bunion); however, the suture system may also be used with other bones and/or may be used for the treatment of cracked and/or broken bone fragments. The suture system includes a suture construct having at least one reduction construct. The reduction construct includes a locking limb, a contractible loop, and an opposed loop disposed generally opposite to the contractible loop. The suture construct is configured to be selectively arranged in an expanded state/position and a reduced state/position. When in the expanded state/position, one or more of the contractible loops are passed through a respective passageway from through a first to the second bone or bone fragment until a portion of the contractible loop(s) extends beyond an opening in the second bone or bone fragment. A suture pin may be passed through the first (and optionally second contractible loop). To reduce/tighten the suture construct into the reduced state/position, the length/size of the opposed loop(s) is reduced thereby reducing the length/size of the first and second contractible loop(s) and biasing the first and second bones/bone fragments towards each other. Once the suture construct applies a desired amount of force to the bones/bone fragments in the reduced state, tension on the suture construct causes the opposed loop(s) to reduce against the locking limb(s), thereby locking, fixing, or otherwise securing the suture construct the reduced state.

With reference to <figref idref="DRAWINGS">FIG. 1</figref>, one embodiment of a suture construct <b>10</b> is generally illustrated. The suture construct <b>10</b> includes one or more reduction constructs (e.g., a first and optionally a second reduction construct <b>28</b>, <b>30</b>). As explained herein, the first and the second reduction constructs <b>28</b>, <b>30</b> (which may have the same or different configuration) are configured to be selectively reduced in size and locked, fixed, or otherwise secured in the reduced formation to apply a compressive force. While the suture construct <b>10</b> is illustrated having two reduction constructs <b>28</b>, <b>30</b> separated by a bridge <b>18</b>, it should be appreciated that a suture construct consistent with the present disclosure may include only one reduction construct <b>28</b>.

The suture construct <b>10</b> may be formed from a single piece of suture <b>12</b>, though it may also be formed from more than one piece of suture <b>12</b>. The suture <b>12</b> may include woven and non-woven sutures, either of which may be formed from one or more threads or fibers. The threads/fibers may all be the same material or may include two or more different materials. The suture <b>12</b> may optionally include one or more coatings such as, but not limited to, antimicrobial materials to reduce potential infection. The suture <b>12</b> may include absorbable or non-absorbable materials. The diameter of the suture <b>12</b> will depend on the intended application; however, the suture <b>12</b> may include, but is not limited to, a #2, #3, #4 and/or #5 suture as defined by the United State Pharmacopeia (U.S.P.), for example, a #4 suture.

With additional reference to <figref idref="DRAWINGS">FIG. 2</figref> (which shows a close-up of region A in <figref idref="DRAWINGS">FIG. 1</figref>), the suture construct <b>10</b> includes the first and second reduction constructs <b>28</b>, <b>30</b>, each separated by a bridge <b>18</b>. The first and second reduction constructs <b>28</b>, <b>30</b> each include a first and a second knot <b>14</b>, <b>16</b>. The first and second knots <b>14</b>, <b>16</b> may include any type of knot which can form a loop <b>20</b>, <b>22</b>, respectively. For example, one or more of the first and second knots <b>14</b>, <b>16</b> may include splice (e.g., a sliding splice or the like), a slip knot, a running bowline, etc. Portions of the suture <b>12</b> are passed through a respective one of the loops <b>20</b>, <b>22</b> to form the first and second reduction constructs <b>28</b>, <b>30</b>. The first and second reduction constructs <b>28</b>, <b>30</b> each include a contractible loop <b>32</b>, <b>34</b> and a opposed loop <b>36</b>, <b>38</b>, each of which are separated by the first and second loops <b>20</b>, <b>22</b>, respectively. A first portion of each of the opposed loops <b>36</b>, <b>38</b> extends through the loops <b>20</b>, <b>22</b> from the contractible loops <b>32</b>, <b>34</b>, respectively, and a second portion of each of the opposed loops <b>36</b>, <b>38</b> extends through the loops <b>20</b>, <b>22</b> and terminates at the first and second free ends <b>24</b>, <b>26</b> of suture (also referred to as the first and second locking limbs <b>24</b>, <b>26</b>). A first portion of each of the contractible loops <b>32</b>, <b>34</b> extends through the loops <b>20</b>, <b>22</b> from the opposed loops <b>36</b>, <b>38</b>, respectively, and a second portion of each of the contractible loops <b>32</b>, <b>34</b> extends from and terminates at the loops <b>20</b>, <b>22</b>.

Optionally, the first and second opposed loops <b>36</b>, <b>38</b> may be temporarily retained in an expanded position (as generally illustrated in <figref idref="DRAWINGS">FIGS. 1 and 2</figref>) using a first and second tab <b>40</b>, <b>42</b>, respectively. The tabs <b>40</b>, <b>42</b> may include, for example, folded pieces of metal (e.g., but not limited to, aluminum), plastic, suture, or the like configured to extend through the opposed loops <b>36</b>, <b>38</b>, thereby preventing the opposed loops <b>36</b>, <b>38</b> from being pulled through the first and second loops <b>20</b>, <b>22</b>, respectively.

Turning now to <figref idref="DRAWINGS">FIGS. 3-7</figref>, embodiments illustrating how the suture system can be used to treat a medical condition are generally illustrated. With reference to <figref idref="DRAWINGS">FIG. 3</figref>, two generally parallel passageways <b>44</b>, <b>45</b> are drilled through a first and second bone <b>46</b>, <b>47</b> (e.g., the first and second metatarsus bones <b>46</b>, <b>47</b>). A drill guide <b>48</b> may be used to form the passageways <b>44</b>, <b>45</b>. In particular, the drill guide <b>48</b> includes two drill bushings/openings <b>50</b><i>a</i>, <b>50</b><i>b </i>spaced apart from each other. The spacing of the bushings <b>50</b><i>a</i>, <b>50</b><i>b </i>is selected based on the size of the bones <b>46</b>, <b>47</b> being drilled. In particular, the spacing may be selected such that the impact on the overall strength of the bones <b>46</b>, <b>47</b> is minimized, thereby reducing the potential of damaging the bones <b>46</b>, <b>47</b>. By way of example, the spacing may be selected within the range of 6-10 mm. It should also be appreciated that the spacing between the first and second splices <b>14</b>, <b>16</b> should generally correspond to the spacing of the bushings <b>50</b><i>a</i>, <b>50</b><i>b. </i>

In practice, the drill guide <b>48</b> may be placed against a portion of the second bone <b>47</b>. A first passing pin or drill bit <b>52</b><i>a </i>(e.g., but not limited to, a 1.2 mm passing pin) is advanced through the first bushing <b>50</b><i>a </i>of the drill guide <b>48</b> to form a first second portions <b>44</b><i>a</i>, <b>44</b><i>b </i>(collectively referred to as the first passageway <b>44</b>) in the first and second bones <b>46</b>, <b>47</b>, respectively. Similarly, a second passing pin or drill bit <b>52</b><i>b </i>is advanced through the second bushing <b>50</b><i>b </i>of the drill guide <b>48</b> to form a first second portions <b>45</b><i>a</i>, <b>45</b><i>b </i>(collectively referred to as the second passageway <b>45</b>) in the first and second bones <b>46</b>, <b>47</b>, respectively. The distal ends <b>53</b> of the first and second drill bits <b>52</b><i>a</i>, <b>52</b><i>b </i>extend beyond the first bone <b>46</b> and the proximal ends <b>55</b> have not passed through the second bone <b>47</b>. The first and second drill bits <b>52</b><i>a</i>, <b>52</b><i>b </i>optionally include a loop or snare <b>54</b><i>a</i>, <b>54</b><i>b </i>extending from the proximal ends <b>55</b>.

With the passageways <b>44</b>, <b>45</b> having been formed, the suture construct <b>10</b> may then be advanced through the passageways <b>44</b>, <b>45</b>. Turning now to <figref idref="DRAWINGS">FIG. 4</figref>, the suture construct <b>10</b> is illustrated in combination with two pull strands <b>56</b>. The pull strands <b>56</b> are disposed around a distal end of the first and second contractible loops <b>32</b>, <b>34</b> and are configured to be releasably coupled to the first and second contractible loops <b>32</b>, <b>34</b>. For example, the pull strands <b>56</b> may include a loop disposed around the first and second contractible loops <b>32</b>, <b>34</b>. The pull strands <b>56</b> may also be tied or otherwise releasably secured to the first and second contractible loops <b>32</b>, <b>34</b>. Optionally, the suture construct <b>10</b> includes a suture plate <b>58</b>. The suture plate <b>58</b> includes two apertures <b>60</b> spaced apart a distance generally corresponding to the distance between the two passageways <b>44</b>, <b>45</b> and the spacing of the first and second knots <b>14</b>, <b>16</b>. The suture plates <b>58</b> may have a “<figref idref="DRAWINGS">FIG. 8</figref>” cross-section or may have a generally rectangular cross-section.

With reference to <figref idref="DRAWINGS">FIGS. 3, 4, and 5</figref>, the pull strands <b>56</b> are configured to be coupled to the loops/snares <b>54</b><i>a</i>, <b>54</b><i>b </i>extending from the drill bits <b>52</b><i>a</i>, <b>52</b><i>b</i>. The drill bits <b>52</b><i>a</i>, <b>52</b><i>b </i>are then retracted through the passageways <b>44</b>, <b>45</b>, thereby advancing the pull strands <b>56</b> through the passageways <b>44</b>, <b>45</b>. Once the pull strands <b>56</b> are beyond the first bone <b>46</b>, the pull strands <b>56</b> can be used to pull/advance a portion of the contractible loops <b>32</b>, <b>34</b> through a respective one of the passageways <b>44</b>, <b>45</b> (from the second bone <b>47</b> and then through the first bone <b>46</b>) until a distal portion of the contractible loops <b>32</b>, <b>34</b> extends beyond the first bone <b>46</b>. The contractible loops <b>32</b>, <b>34</b> may be advanced through the passageways <b>44</b>, <b>45</b> until the bridge <b>18</b> (or the optional suture plate <b>58</b>) is proximate to or abuts against the second bone <b>47</b>, thereafter the pull strands <b>56</b> may be disconnected/released from the first and second contractible loop <b>32</b>, <b>34</b> as generally illustrated in <figref idref="DRAWINGS">FIG. 5</figref>.

With the first and second contractible loops <b>32</b>, <b>34</b> advanced through the passageways <b>44</b>, <b>45</b>, the suture pin <b>62</b> (<figref idref="DRAWINGS">FIG. 5</figref>) is then coupled to the first and second contractible loop <b>32</b>, <b>34</b> such that the suture construct <b>10</b> forms an enclosed loop extending around a portion of the first and second bones <b>46</b>, <b>47</b>. The enclosed loop suture construct is defined by the first and second contractible loops <b>32</b>, <b>34</b>, the bridge <b>18</b>, and the suture pin <b>62</b>. According to one embodiment, the suture pin <b>62</b> is passed through the first and second contractible loops <b>32</b>, <b>34</b> such that a portion of the first and second contractible loops <b>32</b>, <b>34</b> is disposed around a portion of the suture pin <b>62</b>. Alternatively (or in addition), the suture pin <b>62</b> may be secured to the first and second contractible loops <b>32</b>, <b>34</b> using one or more fasteners, clamps, or the like.

The suture pin <b>62</b> may have a length larger than the spacing between the two passageways <b>44</b>, <b>45</b> in the first bone <b>46</b>. Having the length of the suture pin <b>62</b> greater than the spacing between the two passageways <b>44</b>, <b>45</b> in the first bone <b>46</b> allows the first and second contractible loops <b>32</b>, <b>34</b> to extend substantially parallel to the two passageways <b>44</b>, <b>45</b>, thereby minimizing stress placed on the bones <b>46</b>, <b>47</b> by the first and second contractible loops <b>32</b>, <b>34</b>. For example, if the first and second contractible loops <b>32</b>, <b>34</b> are not parallel to the passageways <b>44</b>, <b>45</b>, then the first and second contractible loops <b>32</b>, <b>34</b> will exert a force against the sideways of the passageways <b>44</b>, <b>45</b> and/or the portion of bone between the passageways <b>44</b>, <b>45</b>, causing the first and second contractible loops <b>32</b>, <b>34</b> to dig into and damage the bones <b>46</b>, <b>47</b>.

In addition to having a length greater than the spacing between the two passageways <b>44</b>, <b>45</b> in the first bone <b>46</b>, the suture pin <b>62</b> may also have an overall width, diameter, or cross-section that is greater than the diameter of the passageways <b>44</b>, <b>45</b> such that the suture pin <b>62</b> will not fit within the passageways <b>44</b>, <b>45</b>. As explained herein, the suture pin <b>62</b> consistent with the present disclosure may be coupled to the first and second contractible loops <b>32</b>, <b>34</b> after the first and second contractible loops <b>32</b>, <b>34</b> have been advanced through the passageways <b>44</b>, <b>45</b>. As a result, the suture pin <b>62</b> does not need to be advanced through the passageways <b>44</b>, <b>45</b> and diameter of the passageways <b>44</b>, <b>45</b> may be minimized (i.e., the diameter of the passageways <b>44</b>, <b>45</b> need only be slightly larger than the overall cross-section of the first and second contractible loops <b>32</b>, <b>34</b>). As may be appreciated, the smaller diameter of the passageways <b>44</b>, <b>45</b> minimizes the negative impact on the strength of the bones <b>46</b>, <b>47</b> by reducing the amount of bone material that is removed.

Turning now to <figref idref="DRAWINGS">FIGS. 6-12</figref>, various embodiments of the suture pin <b>62</b> are generally illustrated. For example, <figref idref="DRAWINGS">FIG. 6</figref> generally illustrates a suture pin <b>62</b><i>a </i>having a generally elongated shape. The suture pin <b>62</b><i>a </i>may be formed from metal (e.g., but not limited to, stainless steel, titanium, aluminum, chromium cobalt, and/or any alloy thereof), plastic (e.g., but not limited to, polyether ether ketone (PEEK), polyethylene (PE) such as ultrahigh molecular weight polyethylene (UHMWPE) and high density polyethylene (HDPE), or the like), composite materials (e.g., reinforced plastics such as fiber-reinforced polymers, metal composites, ceramic composites, or the like), sutures (woven and/or non-woven suture), or the like. The suture pin <b>62</b><i>a </i>may have a generally consistent cross-section throughout its length. The suture pin <b>62</b><i>a </i>may have a generally circular cross-section and/or may have a non-circular cross-section (e.g., rectangular, oval, or the like).

With reference to <figref idref="DRAWINGS">FIG. 7</figref>, a suture pin <b>62</b><i>b </i>is illustrated having a main body <b>64</b>, an end region <b>66</b>, and at least one reduced portion <b>68</b> having a smaller cross-section compared to the main body <b>64</b> and/or the end region <b>66</b>. The reduced portion <b>68</b> may include a groove, slot, channel, or the like configured to aid in locating the first and second contractible loops <b>32</b>, <b>34</b> with respect to the suture pin <b>66</b><i>b</i>, and aid in preventing the suture pin <b>62</b><i>b </i>from becoming dislodged with respect to the first and second contractible loops <b>32</b>, <b>34</b> (i.e., aid in securing the first and second contractible loops <b>32</b>, <b>34</b> with respect to the reduced portion <b>68</b>). The reduced portions <b>68</b> may extend radially around only a portion of the suture pin <b>62</b><i>b </i>(e.g., 180 degrees around, 90 degrees around, or the like) or may extend radially around the entire cross-section of the suture pin <b>62</b><i>b</i>. The positions of the reduced portions <b>68</b> may be separated from each other a distance generally corresponding to the distance between the two passageways <b>44</b>, <b>45</b> and the spacing of the first and second splices <b>14</b>, <b>16</b>. While the suture pin <b>62</b><i>b </i>is illustrated having two reduced portions <b>68</b>, it should be appreciated that the suture pin <b>62</b><i>b </i>may include only one or may include more than two reduced portions <b>68</b> which are distributed along the length of the suture pin <b>62</b><i>b</i>. Having more than two reduced portions <b>68</b> may allow the suture pin <b>62</b><i>b </i>to be used to different suture constructs <b>10</b> having different spacing between the first and second splices <b>14</b>, <b>16</b>.

As generally illustrated in <figref idref="DRAWINGS">FIGS. 8-12</figref>, a suture pin <b>62</b> consistent with the present disclosure may also include one or more enlarged portions configured to aid in locating the first and second contractible loops <b>32</b>, <b>34</b> with respect to the suture pin <b>66</b>, and aid in preventing the suture pin <b>62</b> from becoming dislodged with respect to the first and second contractible loops <b>32</b>, <b>34</b> (i.e., aid in securing the first and second contractible loops <b>32</b>, <b>34</b> with respect to the enlarged portions). The enlarged portions may be separated from each other a distance which is generally equal to or greater than the distance between the two passageways <b>44</b>, <b>45</b> and the spacing of the first and second splices <b>14</b>, <b>16</b>.

One embodiment of a suture pin <b>62</b><i>c </i>having an enlarged portion is generally illustrated in <figref idref="DRAWINGS">FIG. 8</figref>. More specifically, the suture pin <b>62</b><i>c </i>is formed from one or more pieces of suture (either woven or non-woven suture). The suture pin <b>62</b><i>c </i>includes enlarged portions <b>70</b> disposed at generally opposite end regions of a main body <b>64</b>. The enlarged portions <b>70</b> have a cross-section that is larger than the cross-section of the main body <b>64</b>. The overall width, diameter, or cross-section of the enlarged portions <b>70</b> may also be greater than the diameter of the passageways <b>44</b>, <b>45</b> such that the suture pin <b>62</b><i>c </i>will not fit within the passageways <b>44</b>, <b>45</b>.

The enlarged portions <b>70</b> may be formed by forming one or more knots (such as, but not limited to, an overhand knot, half hitch knot, square knot, half knot, or the like). The knots may be made from the same piece of suture as the main body <b>64</b>, and/or may include additional pieces of suture. A benefit to a suture pin having an all-suture construction is that is minimizes the amount of different materials used by the suture system. Additionally, tissue may grow into the suture material, thereby reducing the possibility of the suture pin <b>62</b><i>c </i>from migrating with respect to the first and second contractible loops <b>32</b>, <b>34</b>.

Another embodiment of a suture pin <b>62</b><i>d </i>having enlarged portions <b>70</b> is generally illustrated in <figref idref="DRAWINGS">FIG. 9</figref>. The suture pin <b>62</b><i>d </i>may be similar to the suture pin <b>62</b><i>c</i>, however, the suture pin <b>62</b><i>d </i>includes a rigid element/member <b>72</b> over which the suture <b>74</b> is woven, tied, or otherwise secured around. For example, the rigid element <b>72</b> may include an elongated member (e.g., a pin or the like as generally described in <figref idref="DRAWINGS">FIGS. 6, 7, and 10-12</figref>). The combination of the rigid element <b>72</b> and the suture element <b>74</b> may increase the structural rigidity of the suture pin <b>62</b><i>d</i>, thereby facilitating the assembly of the suture system during the surgical procedure. Additionally, the combination of the rigid element <b>72</b> and the suture element <b>74</b> may increase the overall strength of the suture pin <b>62</b><i>d</i>, and may also allow for tissue growth into the suture element <b>74</b> as discussed herein.

Other embodiments of a suture pin <b>62</b><i>e</i>-<b>62</b><i>g </i>having enlarged portions <b>70</b> are generally illustrated in <figref idref="DRAWINGS">FIGS. 10-12</figref>. The suture pins <b>62</b><i>e</i>-<b>62</b><i>g </i>include a generally elongated main body <b>64</b> having enlarged portions <b>70</b> disposed about the proximal end regions. The main body <b>64</b> and the enlarged portions <b>70</b> may be formed as an integral component (e.g., pieces bonded together, which may be made from the same or different materials) or may be formed as a unitary component (i.e., formed as a single component from the same material). The suture pins <b>62</b><i>e</i>-<b>62</b><i>g </i>may be formed from metal (e.g., but not limited to, stainless steel, titanium, aluminum, chromium cobalt, and/or any alloy thereof), plastic (e.g., but not limited to, polyether ether ketone (PEEK), polyethylene (PE) such as ultrahigh molecular weight polyethylene (UHMWPE) and high density polyethylene (HDPE), or the like), or composite materials (e.g., reinforced plastics such as fiber-reinforced polymers, metal composites, ceramic composites, or the like).

The enlarged portions <b>70</b> may have a generally “T” shaped or disc-shaped protrusion extending generally radially outward as generally illustrated in <figref idref="DRAWINGS">FIG. 10</figref> or a may have a generally “L” shaped protrusion extending generally radially outward as generally illustrated in <figref idref="DRAWINGS">FIG. 11</figref>. While the protrusions are illustrated extending radially outward at approximately 90 degrees from the body portion <b>64</b>, it should be appreciated that the protrusions may extend radially outwardly at an angle A from the body portion <b>64</b> in the range of 10 degrees to 170 degrees. Additionally, while the protrusions are illustrated having a generally planar or linear shape, it should be understood that the protrusions may have a non-linear or non-planar shape such as a curved or arcuate shape. The enlarged portions <b>70</b> may also have a generally circular or cross-section, spherical shape, and/or may have a non-circular cross-section (e.g., rectangular, oval, or the like) as generally illustrated in <figref idref="DRAWINGS">FIG. 12</figref>.

Turning back to <figref idref="DRAWINGS">FIG. 5</figref>, with the suture pin <b>62</b> extending between the first and second contractible loops <b>32</b>, <b>34</b>, the first and second contractible loops <b>32</b>, <b>34</b> may be pulled away from the first bone <b>46</b> to urge the suture pin <b>62</b> against the first bone <b>46</b>, thereby aiding in maintaining the suture pin <b>62</b> within the first and second contractible loops <b>32</b>, <b>34</b>. The first and second tabs <b>40</b>, <b>42</b> are removed from the first and second opposed loops <b>36</b>, <b>38</b> and a pusher <b>76</b> is advanced through the first and second opposed loops <b>36</b>, <b>38</b> as generally illustrated in <figref idref="DRAWINGS">FIG. 13</figref>.

The pusher <b>76</b> is configured to aid in reducing/tightening the suture system and to urge the first and second bones <b>46</b>, <b>47</b> towards each other. According to one embodiment, the pusher <b>76</b> includes a pivoting section <b>78</b> which is advanced through the first and second opposed loops <b>36</b>, <b>38</b> and a pull snare <b>77</b> extending outward beyond the distal end <b>79</b> of the pivoting section <b>78</b>. The pivoting section <b>78</b> optionally extends at an angle from an arm section <b>80</b>. While the angle between the pivoting section <b>78</b> and the arm section <b>80</b> is illustrated at approximately 90 degrees, it should be appreciated that the angle therebetween will depend on the application and the surgeon's preference and may, for example, be in the range of 45 to 135 degrees. The pusher <b>76</b> also optionally includes a handle portion <b>82</b> coupled to the arm section <b>80</b> to aid in gripping the pusher <b>76</b>.

To reduce/tighten the suture system, the surgeon pulls the locking limbs <b>24</b>, <b>26</b> of the suture construct <b>10</b> away from the second bone <b>47</b> while simultaneously urging the pusher <b>76</b> towards the second bone <b>47</b>, thereby reducing the length of the first and second contractible loops <b>32</b>, <b>34</b> and applying a compressive force through the first and second contractible loops <b>32</b>, <b>34</b>, the bridge <b>18</b> (and the optional suture plate <b>58</b>), and suture pin <b>62</b> to bias the first and second bones <b>46</b>, <b>47</b> towards each other. More specifically, the length of the locking limbs <b>24</b>, <b>26</b> of the suture construct <b>10</b> is extended as a portion of the suture <b>12</b> is pulled from the first and second contractible loops <b>32</b>, <b>34</b> and through the opposed loops <b>36</b>, <b>38</b>. The pusher <b>76</b> prevents the opposed loops <b>36</b>, <b>38</b> from self-collapsing as the locking limbs <b>24</b>, <b>26</b> are pulled and effectively acts as a pulley.

Once the suture system applies a desired amount of force to urge the first and second bones <b>46</b>, <b>47</b> towards each other, the locking limbs <b>24</b>, <b>26</b> of the suture construct <b>10</b> are advanced into and captured by the pull snare <b>77</b> extending out from the distal end <b>79</b> of the pusher <b>76</b>. The pusher <b>76</b> is then retracted through the first and second opposed loops <b>36</b>, <b>38</b>, causing a least a portion of the locking limbs <b>24</b>, <b>26</b> to pass through the opposed loops <b>36</b>, <b>38</b> as generally illustrated in <figref idref="DRAWINGS">FIG. 14</figref>. The tension on the suture construct <b>10</b> causes the opposed loops <b>36</b>, <b>38</b> to reduce against the locking limbs <b>24</b>, <b>26</b>, thereby locking the suture construct <b>10</b> and preventing the suture construct <b>10</b> from loosening. Once the suture construct <b>10</b> is locked, excess lengths of the locking limbs <b>24</b>, <b>26</b> may be trimmed proximate to the opposed loops <b>36</b>, <b>38</b>.

Turning now to <figref idref="DRAWINGS">FIGS. 15-18</figref>, the steps for forming one embodiment of a suture construct <b>10</b> consistent with one embodiment of the present disclosure is generally illustrated. With reference to <figref idref="DRAWINGS">FIG. 15</figref>, a length of suture <b>12</b> is provided and the spacing between the first and second knots <b>14</b>, <b>16</b> is determined based on the desired spacing between the first and second passageways <b>44</b>, <b>45</b>. Turning now to <figref idref="DRAWINGS">FIG. 16</figref>, the first and second knots <b>14</b>, <b>16</b> are formed in the suture <b>12</b> (for example, but not limited to, using any splicing technique known to those skilled in the art) and are separated by the bridge <b>18</b>. The first and second loops <b>20</b>, <b>22</b> are also formed as a result of forming the first and second knots <b>14</b>, <b>16</b>, respectively. Intermediate portions <b>84</b>, <b>86</b>, <figref idref="DRAWINGS">FIG. 17</figref>, of the suture <b>12</b> are then passed through the first and second loops <b>20</b>, <b>22</b> to form the first and second contractible loops <b>32</b>, <b>34</b> and the first and second opposed loops <b>36</b>, <b>38</b> as generally illustrated in <figref idref="DRAWINGS">FIG. 18</figref>.

With reference to <figref idref="DRAWINGS">FIG. 19</figref>, another embodiment of a suture system <b>1</b><i>a </i>is generally illustrated. The suture system <b>1</b><i>a </i>includes a suture construct <b>10</b><i>a</i>, a first and a second pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>), a suture pin <b>62</b> (not shown for clarity), and optionally a suture plate <b>58</b> (also not shown for clarity). The suture construct <b>10</b><i>a </i>is similar to the suture construct <b>10</b> described herein, except that the first and second opposed loops <b>36</b>, <b>38</b> have been lengthened, the locking limbs <b>24</b>, <b>26</b> of the suture <b>12</b> have been advanced through the opposed loops <b>36</b>, <b>38</b>, and the lumens <b>101</b>(<b>1</b>), <b>101</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) have been advanced over a portion of the opposed loops <b>36</b>, <b>38</b> such that a distal portion <b>102</b>(<b>1</b>), <b>102</b>(<b>2</b>) of the opposed loops <b>36</b>, <b>38</b> extends beyond a distal end <b>104</b>(<b>1</b>), <b>104</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>). The proximal ends <b>106</b>(<b>1</b>), <b>106</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) are proximate to and/or abuts against the splice snares <b>20</b>, <b>22</b> and/or the splices <b>14</b>, <b>16</b>, respectively. Optionally, the “hot side” <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>) of the opposed loops <b>36</b>, <b>38</b> may be marked, for example, using one or more marking indicia, tabs <b>110</b> or the like. As used herein, the term “hot sides” of the opposed loops <b>36</b>, <b>38</b> refers to the portions of the opposed loops <b>36</b>, <b>38</b> which pass through the first and second loops <b>20</b>, <b>22</b> from the first and second contractible loops <b>32</b>, <b>34</b> when the first and second contractible loops <b>32</b>, <b>34</b> are reduced in size.

The suture construct <b>10</b><i>a </i>of the system <b>1</b><i>a </i>is installed in the first and second bones <b>46</b>, <b>47</b> in a manner similar to the suture construct <b>10</b>. For the sake of brevity, all of the installation steps of the suture system <b>1</b><i>a </i>have not been repeated, and reference is made to the remainder of the instant application. Specifically, the passageways <b>44</b>, <b>45</b> may be formed in the bones <b>46</b>, <b>47</b> and the contractible loops <b>32</b>, <b>34</b> are advanced through a respective one of the passageways <b>44</b>, <b>45</b> (from the second bone <b>47</b> and then through the first bone <b>46</b>) until a distal portion of the contractible loops <b>32</b>, <b>34</b> extends beyond the first bone <b>46</b> in the same manner as described herein. The contractible loops <b>32</b>, <b>34</b> may be advanced through the passageways <b>44</b>, <b>45</b> until the bridge <b>18</b> (or the optional suture plate <b>58</b>) is proximate to or abuts against the second bone <b>47</b>. With the first and second contractible loops <b>32</b>, <b>34</b> advanced through the passageways <b>44</b>, <b>45</b>, a suture pin <b>62</b> is then coupled to the first and second contractible loops <b>32</b>, <b>34</b> such that the suture construct <b>10</b> forms an enclosed loop extending around a portion of the first and second bones <b>46</b>, <b>47</b> in the same manner described herein. With the suture pin <b>62</b> extending between the first and second contractible loops <b>32</b>, <b>34</b>, the first and second contractible loops <b>32</b>, <b>34</b> may be pulled away from the first bone <b>46</b> to urge the suture pin <b>62</b> against the first bone <b>46</b>, thereby aiding in maintaining the suture pin <b>62</b> within the first and second contractible loops <b>32</b>, <b>34</b>.

Whereas the reduction of the suture construct <b>10</b> utilized a pusher <b>76</b>, the installation and reduction of the suture construct <b>10</b><i>a </i>replaces the pusher <b>76</b> and utilizes one or more pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) instead. More specifically, with the suture pin <b>62</b> extending between the first and second contractible loops <b>32</b>, <b>34</b> and urged against the first bone <b>46</b>, the user grasps the hot sides <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>) (for example, using a gripper, grasper, forceps, <b>112</b> or the like as generally illustrated in <figref idref="DRAWINGS">FIG. 20</figref>) of the opposed loops <b>36</b>, <b>38</b> and pulls the hot sides hot sides <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>) through the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) and distally or away from the contractible loops <b>32</b>, <b>34</b> (for example, but not limited to, rotating or twisting the forceps <b>112</b> against a distal end <b>104</b>(<b>1</b>), <b>104</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) as generally illustrated in <figref idref="DRAWINGS">FIG. 21</figref>). The pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) may have a length sufficient to allow the surgeon to operate on the distal ends <b>104</b>(<b>1</b>), <b>104</b>(<b>2</b>) outside of the patient's tissue.

As may be appreciated, pulling the hot sides <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>) of the opposed loops <b>36</b>, <b>38</b> causes the length of the contractible loops <b>32</b>, <b>34</b> to be reduced since the hot sides <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>) are slidably coupled to the contractible loops <b>32</b>, <b>34</b> through the loops <b>20</b>, <b>22</b>. Reducing the lengths of the opposed loops <b>36</b>, <b>38</b> applies a compressive force through the first and second contractible loops <b>32</b>, <b>34</b>, the bridge <b>18</b> (and the optional suture plate <b>58</b>), and suture pin <b>62</b> to bias the first and second bones <b>46</b>, <b>47</b> towards each other. Once the desired amount of compressive force is applied to the bones <b>46</b>, <b>47</b>, the suture construct <b>10</b><i>a </i>may be temporally maintained in the compressed state by urging the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) against the loops <b>20</b>, <b>22</b> and/or the knots <b>14</b>, <b>16</b>, and the tension on the hot sides <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>) (e.g., by means of the forceps <b>112</b>) may be temporarily eliminated. While urging the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) against the loops <b>20</b>, <b>22</b> and/or the knots <b>14</b>, <b>16</b>, the user may then pull on the locking limbs <b>24</b>, <b>26</b> of the suture construct <b>10</b><i>a</i>. As noted above, the locking limbs <b>24</b>, <b>26</b> are already passed through the opposed loops <b>36</b>, <b>38</b>. As the user pulls on the locking limbs <b>24</b>, <b>26</b>, the length of the opposed loops <b>36</b>, <b>38</b> decreases until the opposed loops <b>36</b>, <b>38</b> are compressed against the locking limbs <b>24</b>, <b>26</b> extending therethrough. The tension on the suture construct <b>10</b><i>a </i>causes the opposed loops <b>36</b>, <b>38</b> to reduce against the locking limbs <b>24</b>, <b>26</b>, thereby locking the suture construct <b>10</b><i>a </i>and preventing the suture construct <b>10</b><i>a </i>from loosening. Once the suture construct <b>10</b><i>a </i>is locked, excess lengths of the locking limbs <b>24</b>, <b>26</b> may be trimmed proximate to the opposed loops <b>36</b>, <b>38</b>.

The pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) optionally include one or more outriggers <b>114</b> extending generally outward from the distal ends <b>104</b>(<b>1</b>), <b>104</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>), for example, outwardly from the longitudinal axis of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) as generally illustrated in <figref idref="DRAWINGS">FIG. 21</figref>. The outriggers <b>114</b> may facilitate pulling the hot sides <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>) of the opposed loops <b>36</b>, <b>38</b> through the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>). More specifically, the outrigger <b>114</b> is configured to provide an increased area against which the forceps or other grasper <b>112</b> may contact against.

With reference to <figref idref="DRAWINGS">FIG. 22</figref>, the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) may include a plurality of outriggers <b>114</b>(<b>1</b>)-<b>114</b>(<i>n</i>) extending generally outwardly from the distal ends <b>104</b>(<b>1</b>), <b>104</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>). For example, the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) may include a first and a second outrigger <b>114</b>(<b>1</b>), <b>114</b>(<i>n</i>) which extend outward from generally opposite sides of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>), e.g., the first and second outriggers <b>114</b>(<b>1</b>), <b>114</b>(<b>2</b>) to form a cradle-like structure configured to reduce and/or prevent the forceps/graspers <b>112</b> from slipping off the distal ends <b>104</b>(<b>1</b>), <b>104</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) as the forceps/graspers <b>112</b> are rotated or twisted. For example, the first and second outriggers <b>114</b>(<b>1</b>), <b>114</b>(<b>2</b>) may be disposed approximately 180 degrees from each other. It should be appreciated, however, that the first and second outriggers <b>114</b>(<b>1</b>), <b>114</b>(<b>2</b>) may be disposed at any other angle relative to each other to form a crook. For example, the first and second outriggers <b>114</b>(<b>1</b>), <b>114</b>(<b>2</b>) may be disposed at an angle less than 180 degrees relative to each other, for example, an obtuse angle as generally illustrated in <figref idref="DRAWINGS">FIG. 23</figref>.

Optionally, one or more of the proximal ends <b>160</b>(<b>1</b>), <b>106</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) may include a taper <b>116</b> to aid in visualization of the tip. Additionally, the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) may optionally include one or more apertures <b>118</b>. The apertures <b>118</b> may facilitate sterilization of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) by allowing the sterilization medium to more easily flow through the lumens <b>101</b>(<b>1</b>), <b>101</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) and/or may facilitate molding of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) by allowing pins to be aligned through the apertures <b>118</b> to aid in aligning a centering pins disposed through the lumens <b>101</b>(<b>1</b>), <b>101</b>(<b>2</b>).

The pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) facilitate the reduction of the suture construct <b>10</b><i>a</i>. In particular, the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) allow the user to pull the suture <b>12</b> (e.g., the hot sides <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>)) from the opposed loops <b>36</b>, <b>38</b> linearly through the first and second loops <b>20</b>, <b>22</b>, thereby allowing a user to more easily apply a much greater amount of compressive force through the suture system <b>1</b><i>a</i>. Moreover, rotating/twisting the hot sides <b>108</b>(<b>1</b>), <b>108</b>(<b>2</b>) using the forceps <b>112</b> on the distal ends <b>104</b>(<b>1</b>), <b>104</b>(<b>2</b>) of the pusher tubes <b>100</b>(<b>1</b>), <b>100</b>(<b>2</b>) creates a mechanical advantage (e.g., a pulley-like effect) which greatly increases the amount of compressive force which may be applied through the suture system <b>1</b><i>a. </i>

Turning now to <figref idref="DRAWINGS">FIGS. 24-30</figref>, another embodiment of a suture pin <b>62</b><i>h </i>is generally illustrated. In particular, <figref idref="DRAWINGS">FIGS. 24 and 25</figref> generally illustrate one embodiment of a suture construct <b>10</b><i>a </i>in combination with the suture pin <b>62</b><i>h </i>for securing two bone fragments <b>125</b><i>a</i>, <b>125</b><i>b</i>. <figref idref="DRAWINGS">FIG. 26</figref> generally illustrates one embodiment of a suture construct <b>10</b><i>a </i>in combination with the suture pin <b>62</b><i>h </i>for securing two bones <b>46</b>, <b>47</b>. <figref idref="DRAWINGS">FIGS. 27-30</figref> generally illustrate various views of the suture pin <b>62</b><i>h</i>. As will described in more detail herein, the suture pin <b>62</b><i>h </i>reduces the amount of friction and/or force required to reduce the suture construct, thereby providing a greater tactile feel to the surgeon, minimizing potential damage to the bones/bone fragments, and/or providing sufficient strength/rigidity to the suture pin to prevent damage/failure of the suture pin while reducing the suture construct.

As may be appreciated, the main body of the suture pin should be strong enough to prevent failure when reducing the suture construct. Put another way, if the suture pin is not strong enough, then the forces exerted against the suture pin by the suture construct will excessively bend the suture pin causing an unacceptable amount of deformation of the suture pin which can lead to bone damage or failure of the suture pin. As the cross-sectional thickness of the suture pin is increased, however, the main body of the suture pin begins to close/cover-over the opening in the bone defined by the passageway therethrough. An example of this is illustrated in <figref idref="DRAWINGS">FIG. 31</figref>. In particular, a cross-section of a suture pin <b>62</b> and the opening <b>120</b> of passageway <b>44</b> in the bone <b>46</b> is generally illustrated. The suture pin <b>62</b> includes a rectangular main body <b>64</b> over which the contractible loop <b>32</b> slides. Because the cross-sectional thickness of the main body <b>64</b> (i.e., the portion of the suture pin which extends across the opening <b>120</b>) is larger than the diameter of the opening <b>120</b> to provide sufficient strength to the suture pin <b>62</b>, the main body <b>64</b> will cover or block the opening <b>120</b>. As the main body <b>64</b> blocks the opening <b>120</b>, the contractible loop <b>32</b> is forced to travel between the main body <b>64</b> and the opening <b>120</b> and/or the contractible loop <b>32</b> is forced to cut a groove into the bone <b>46</b> in the area proximate to the opening <b>120</b> when the suture construct is reduced. Consequently, the suture pin <b>62</b> significantly increases the friction/resistance and reduces the tactile feel when reducing the suture construct.

In addition, the rectangular cross-section of the main body <b>64</b> significantly increases the amount of friction when reducing the suture construct. In particular, because the contractible loop <b>32</b> is forced to travel between the main body <b>64</b> and the opening <b>120</b>, the contractible loop <b>32</b> must slide across the four corners <b>122</b><i>a</i>, <b>122</b><i>b</i>, <b>122</b><i>c </i><b>122</b><i>d </i>of the main body <b>64</b> as well as two portion portions <b>124</b><i>a</i>, <b>124</b><i>b </i>of the perimeter of the opening <b>120</b>. The four corners <b>122</b><i>a</i>, <b>122</b><i>b</i>, <b>122</b><i>c </i><b>122</b><i>d </i>and portions <b>124</b><i>a</i>, <b>124</b><i>b </i>generate a very high stress and/or friction concentrations, thereby increasing the overall amount of force necessary to slide the contractible loop <b>32</b> when reducing the suture construct.

Referring back to <figref idref="DRAWINGS">FIGS. 24-30</figref>, the suture pin <b>62</b><i>h </i>is configured to minimize and/or eliminate the above described issues. In particular, the suture pin <b>62</b><i>h </i>includes a main body <b>64</b> having a generally circular cross-section extending between a first and a second enlarged portion <b>70</b>. The main body <b>64</b> may include a length which is greater than the spacing of the bridge <b>18</b> to compensate for non-parallel passageways <b>44</b>, <b>45</b>. For example, for a bridge having a length of 10 mm, the main body <b>64</b> may include a length of 17 mm to 20 mm. The diameter of the main body <b>64</b> should be selected to prevent an undesirable amount of deformation and/or failure of the suture pin <b>62</b><i>h </i>based on the intended use of the suture construct. By way of an example, a suture pin <b>62</b><i>h </i>constructed from a titanium alloy used with a suture construct having a #4 suture to treat hallux valgus may include a main body <b>64</b> having a diameter of approximately 1 mm (which may be approximately equal to the diameter of the passageway <b>44</b>). It should be appreciated, thought, that this is just an example, and that the diameter of the main body <b>64</b> of the suture pin <b>62</b><i>h </i>will depend on the intended application as well as the intended forces exerted by the suture system during reduction.

With reference to <figref idref="DRAWINGS">FIG. 32</figref>, a cross-section of the main body <b>64</b> of the suture pin <b>62</b><i>h </i>is illustrated along with the contractible loop <b>32</b> extending through the opening <b>120</b> of the passageway <b>44</b>. Depending on the diameter of the main body <b>64</b>, the suture pin <b>62</b><i>h </i>may eliminate the friction points (e.g., when the diameter of the main body <b>64</b> is less than the diameter of the opening <b>120</b> of the passageway <b>44</b>) or may have only two friction points <b>104</b><i>a</i>, <b>124</b><i>b </i>which correspond to the locations where the contractible loop <b>32</b> passes between the main body <b>64</b> and the opening <b>120</b> (e.g., when the diameter of the main body <b>64</b> is equal to or greater than the diameter of the opening <b>120</b> of the passageway <b>44</b>). The generally circular cross-section of the main body <b>64</b> acts as a pulley, thereby allowing the contractible loop <b>32</b> to slide smoothly around a portion of the perimeter of the main body <b>64</b> (e.g., greater than or equal to 180 degrees around the main body <b>64</b>) as the contractible loop <b>32</b> is reduced. As a result, the suture pin <b>62</b><i>h </i>with a main body <b>64</b> having a generally circular cross-section reduces the amount of friction and/or force required to reduce the suture construct. Additionally, the reduction in friction points allows the suture pin <b>62</b><i>h </i>to provide a greater tactile feel to the surgeon and minimizes potential damage to the bones/bone fragments. Moreover, the overall strength of the suture pin <b>62</b><i>h </i>may be increased while preventing/minimizing the suture pin <b>62</b><i>h </i>from covering/blocking the opening <b>120</b> of the passageway <b>44</b>.

With reference again to <figref idref="DRAWINGS">FIGS. 24-30</figref>, the enlarged portions <b>70</b> of the suture pin <b>62</b><i>h </i>may include a bone facing surface <b>126</b> having a generally concaved contour. The concaved contour is configured to allow the bone facing surface <b>126</b> to generally conform to the bone surface, e.g., to allow the bone facing surface <b>126</b> to sit generally congruent with the bone face. The concaved bone facing surface <b>126</b> helps distribute the forces exerted by the suture system more evenly across the bone <b>46</b> and also helps position the suture pin <b>62</b><i>h </i>during assembly/implanting of the suture system within passageway(s) <b>44</b>, <b>45</b>.

One or more of the enlarged portions <b>70</b> of the suture pin <b>62</b><i>h </i>may also feature one or more shoulders <b>127</b> extending outwardly beyond the main body <b>64</b>. For example, the shoulders <b>127</b> may form a generally an arrowhead-like shape which extend outward and generally towards the opposite end (though the shoulders <b>127</b> may extend outward generally perpendicularly from the main body <b>64</b> or outward generally away from the opposite end). As discussed herein, the enlarged portions <b>70</b> may aid in keeping the contractible loop(s) <b>32</b>, <b>34</b> disposed on the main body <b>64</b> during assembly/implanting of the suture system within passageway(s) <b>44</b>, <b>45</b>.

While the main body <b>64</b> is described having a generally circular cross-section, it may be appreciated that the main body <b>64</b> may also include a generally oval cross-section. Additionally, while the entire main body <b>64</b> is illustrated having a generally circular, it may be appreciated that only the portions or regions of the main body <b>64</b> over which the contractible loop(s) <b>28</b>, <b>30</b> slide when reducing the suture construct may have a generally circular or oval cross-section. Moreover, while the suture pin <b>62</b><i>h </i>is illustrated having a first and a second enlarged portion <b>70</b>, it may be appreciated that the main body <b>64</b> may extend between one or more reduced portions as disclosed herein.

Variations of the suture system and suture construct described herein are considered to be part of this disclosure. For example, while the suture construct the suture construct described above is generally symmetrical about the bridge (e.g., the suture construct is illustrated having first and second knots, first and second loops, first and second contractible loops, and first and second opposed loops separated by the bridge), the bridge section may be eliminated and the suture construct may feature only one half of the remaining construct (i.e., a single reduction construct). More specifically, the suture construct may alternatively include only one knot, one loop, one contractible loop, and one opposed loop. The contractible loop may be passed through a single passageway formed through the first and second bones. A first suture pin may be disposed through a distal end of the contractible loop against the first bone and a second splice pin may be disposed through a proximal end of the contractible loop against the second bone. The suture construct may then be tightened by pulling on the locking limb of the suture using a pusher or pusher tube as generally described herein. Once the desired amount of force is applied by the suture construct, the tension on the suture construct causes the opposed loop to reduce against the locking limb, thereby locking the suture construct and preventing the suture construct from loosening. Once the suture construct is locked, the locking limb may be trimmed proximate to the opposed loop.

One or more of the suture systems consistent with the present disclosure provide numerous advantages. For example, the suture systems may include an all thread (suture) repair device which does not require the surgeon to tie any knots, welds, or the like in order to secure and/or draw the suture system tight. The elimination of knots is significant because many surgeons are uncomfortable tying knots due to the possibility of the knot becoming loose and/or the difficulty associated with tying a knot during a surgical procedure. Additionally, welding increases the possibility of accidental collateral damage to surrounding tissue and may be difficult during a surgical procedure.

Additionally, the suture systems consistent with the present disclosure eliminate the need to pass buttons, pledgets, or the like through passageways formed in the bone. As a result, the passageways formed in the bone may have a smaller diameter and may minimize the potential of causing incidental complications (such as, but not limited to, damaging the bones during drilling and/or cracking the bones after installation).

The suture systems consistent with the present disclosure also provide an “equilibrium” construct. More specifically, the suture systems consistent with the present disclosure distribute the compressive force generated by the suture system evenly across the entire suture system. In contrast, other suture systems utilize two separate and distinct sutures. Consequently, one suture may exert more compressive force than the other suture. This uneven compressive force may place additional stress on the tissue and/or bones, and may lead to the tissue or bones failing.

According to one aspect, the present disclosure features a suture system including a suture construct having a first reduction construct configured to be selectively arranged in an expanded state and a reduced state. The first reduction construct includes a first locking limb, a first contractible loop, and a first opposed loop disposed generally opposite to the first contractible loop, wherein reduction of the first opposed loop contracts the first contractible loop from the expanded state into the reduced state and secures the suture construct in the reduced state. The suture construct may also include a second reduction construct.

According to another aspect, the present disclosure features a suture system including a first and a second reduction construct separated by a bridge. Each of the reduction constructs features a knot defining a loop, a contractible loop and an opposed loop separated by the loop, and a locking limb extending from the loop and the opposed loop. Each of the reduction constructs is configured to be selectively reduced from an expanded state to a reduced state by reducing a length of the contractible loop by urging the locking limb through the loop from the opposed loop, thereby advancing a portion of the contractible loop through the loop and into the opposed loop.

According to yet another aspect, the present disclosure features a suture system including a first and a second reduction construct separated by a bridge. Each of the reduction constructs is configured to be selectively arranged in an expanded state and a reduced state and each includes a locking limb, a contractible loop, and an opposed loop disposed generally opposite to the contractible loop. Reduction of the opposed loop contracts the contractible loop from the expanded state into the reduced state and secures the suture construct in the reduced state.

According to yet a further aspect, the present disclosure features a suture pin including a first and a second enlarged portion and an elongated body portion extending between the first and the second enlarged portion. The elongated body portion has a generally circular cross-section. The first and the second enlarged portion have a cross-section which greater than a cross-section of the elongated body portion.

According to another aspect, the present disclosure features a method for securing two bones together using a suture system. The method includes forming a first and a second passageway, each extending through a first and a second bone; advancing a distal portion of a first and a second contractible loop through a respective one of the first and the second passageways until the distal ends extend beyond the first bone, wherein proximal regions of the first and the second contractible loops are separated by a bridge, the bridge being disposed proximate to the second bone; advancing a suture plate through the distal portion of the first and the second contractible loops extending beyond the first bone; and reducing the first and the second contractible loops disposed within the first and the second passageways by advancing a first and a second locking limb from a first and a second opposed loop and through a first and a second loop, respectively, thereby advancing portions of the first and second contractible loops through the first and the second loops and into the first ands second opposed loops.

According to yet a further aspect, the present disclosure features a method for forming a suture construct. The method includes providing a length of suture; forming a first and a second knot and a first and a second loop, respectively, in the suture, the first and second knots being separated by a bridge; and passing intermediate portions of the suture through the first and the second loops to form a first and a second contractible loop and a first and a second opposed loop, respectively, wherein a first and a second locking limb extends from the first and the second opposed loops through the first and the second loops, respectively.

It should be appreciated that various features of the different embodiments described herein may be combined together.

While the principles of the present disclosure have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. The features and aspects described with reference to particular embodiments disclosed herein are susceptible to combination and/or application with various other embodiments described herein. Such combinations and/or applications of such described features and aspects to such other embodiments are contemplated herein. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention, which is not to be limited except by the following claims.

All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.

All references, patents and patent applications and publications that are cited or referred to in this application are incorporated in their entirety herein by reference.

Additional disclosure in the format of claims is set forth below: